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mhra

Touchlight’s dbDNA™ Manufacturing Facility Receives World-First GMP License from MHRA

Touchlight dbDNA™ MHRA

Touchlight, an innovation-driven Contract Development and Manufacturing Organisation (CDMO), today announced that its facility in Hampton UK has received GMP certification.

January 14, 2025 by PharmaSources

Early risers: life-changing medical scheme given legal revitalisation

MHRA EAMS medicines

Boost for patients with life-threatening conditions who require access to medicines not yet authorised for marketing.

February 3, 2022 by pharmatimes

Voxelotor for haemolytic anaemia treatment gains positive opinion

haemolytic anaemia GBT MHRA

MHRA awards a positive scientific opinion for voxelotor–a once-daily tablet for the treatment of haemolytic anaemia.

January 27, 2022 by pharmatimes

UK MHRA grants approval to Pfizer’s oral antiviral for Covid-19

MHRA Paxlovid Covid-19

In a trial, Paxlovid, given within three days of symptom onset, lowered hospitalisation and death risk within 28 days by 89%.

January 4, 2022 by Pharmaceutical-Technology

MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill

COVID-19 Paxlovid MHRA

Pfizer’s Paxlovid has a success rate of nearly 90% as a prophylaxis treatment against severe COVID-19 when administered shortly after the patient has been infected with the virus.

January 4, 2022 by pharmatimes

COVID-19 vaccine should be offered to vulnerable children aged five to 11-years-old

COVID-19 vaccine MHRA

Government vaccine advisers have said vulnerable primary school children should be offered a low-dose of a COVID-19 vaccine.

December 23, 2021 by pharmatimes

Northwest Biotherapeutics Receives MHRA Approval of License for GMP Manufacturing in UK

NW BIO DCVax-L MHRA

Enables the manufacturing of DCVax-L products to get under way at the Sawston facility.

December 22, 2021 by contractpharma

UK regulator publishes guidance on use of real-world data to support clinical trials

MHRA clinical trial RWD

Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.

December 20, 2021 by EuropeanPharmaceuticalReview

Health minister welcomes new treatments for COVID-19 patients

COVID-19 MHRA Xevudy

The treatments are being offered as an addition to vaccinations to maximise protection against COVID-19.

December 13, 2021 by PharmaTimes

UK’s MHRA grants authorisation for GSK-Vir Biotechnology’s Covid-19 drug

MHRA Covid-19 sotrovimab

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation for GSK and Vir Biotechnology’s investigational Covid-19 therapy, Xevudy (sotrovimab).

December 6, 2021 by Pharmaceutical-Technology

MHRA approves Xevudy (sotrovimab) to treat COVID-19

MHRA sotrovimab COVID-19

The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.

December 3, 2021 by EuropeanPharmaceuticalReview

MHRA approves for Epidyolex® (cannabidiol) for TSC seizure treatment

MHRA Epidyolex TSC GW

GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.

August 13, 2021 by europeanpharmaceuticalreview